MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC STAR S4 IR; EXCIMER LASER SYSTEM

Model Number	UNK-EXCIMER
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced decentration in her right eye following femtolasik surgery with visx star s4 ir excimer laser.During the procedure in the right eye, the excimer laser was unable to identify the pupil for an extended period, requiring multiple adjustments to the head position, laser intensity, and room lighting, as well as repeated instructions to the patient to maintain proper gaze.The laser intermittently lost pupil tracking throughout the procedure, causing repeated interruptions.The patient also exhibited involuntary upward eye movement, possibly due to fatigue from the prolonged procedure.Despite these challenges, the procedure was completed as planned.The left eye procedure was uneventful.Postoperatively, the patient¿s right eye vision was significantly worse than the left, with no effective corrective options and persistent glare, particularly at night, which impaired her ability to drive.At the (b)(6) month follow-up, there was no improvement in the right eye¿s vision.The suspected cause was decentration of the ablation in the right eye.No adverse events were reported for the left eye, and no additional patient harm was described beyond the visual symptoms in the right eye.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - model #, catalogue #, expiration date, serial #: unknown/not provided.Section d6a - implant date: not applicable.Laser equipment is not an implantable device.Section d6b - explant date: not applicable.Laser equipment is not an implantable device; therefore, not explanted.Section e1: first/given name: unknown, as information was requested but not provided section e1 : last name: unknown, as information was requested but not provided section e1 :email address: unknown, as information was requested but not provided section e1 : establishment name, address, city and post office or zip code: unknown, as information was requested but not provided section e1: (b)(6).Section h3 - the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h4 - device manufacture date: unknown, as the serial number of the device was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: STAR S4 IR
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24258622
• Report Number: 3012236936-2026-000027
• Device Sequence Number: 7893988
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P910062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UNK-EXCIMER
• Device Catalogue Number: 0030-4864
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female